A New Cures Act, a New Research Beginning

Winter is here; the days are getting longer. That's not just my optimism shining through. It’s a truth based on astronomy. Every new day is bringing a few more minutes of daylight to our northern hemisphere dwellings…and raising our spirits.

Many cultures through history marked the new year in the spring, at the vernal equinox in March when the daytime and nighttime at the equator are equal lengths, 12 hours each. That certainly makes sense: Spring is a time of renewal, as the earth is giving birth to new crops. The ancient Babylonians celebrated the new year during the equinox, a remnant of which is seen today in the observation of Naw-Rúz in the Bahá’í tradition and similar holidays in Turkey, Iran, Afghanistan and Pakistan. The Romans also started the new year in March, which is why September, October, November, and December were considered the 7th, 8th, 9th, and 10th months. It was only later in the empire, under the rule of Julius Caesar, that the new year officially changed to January 1.

The 21st Century Cures Act establishes the NIH Innovation Account in the U.S. Treasury to carry out the Precision Medicine Initiative ($1.45B), the BRAIN Initiative ($1.5B), cancer research ($1.8B), and regenerative medicine ($30M) over a ten-year period. The Act also reauthorizes the NIH at the following levels: $34.85 billion for fiscal year (FY) 2018; $35.56 billion for FY 2019; and $36.47 billion for FY 2020. An additional $1 billion of non-NIH money will be available for grants to states to supplement opioid abuse prevention and treatment activities.

There are many fine details in the Act that will benefit the broader biomedical research community. For example, the Act creates a ‘Next Generation of Researchers Initiative’ within the NIH Office of the Director (OD) to coordinate, develop, modify, and prioritize policies and programs to improve opportunities for new researchers, for which we will work with the National Academy of Sciences. The NIH Director also can now target the loan repayment programs to meet workforce or scientific needs related to biomedical research by eliminating loan repayment subcategories or by adding a limited number of new subcategories.

Other highlights of the Act can be summed up in the naming of section titles: Sec. 2034. Reducing Administrative Burden for Researchers; Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act Requirements; Sec. 2036. High-Risk, High- Reward Research; "Sec. 2042. Streamlining National Institutes of Health Reporting Requirements; Sec. 2044. Sense of Congress on Increased Inclusion of Underrepresented Populations in Clinical Trials; and much more. We don’t yet know specifically how some of these provisions will play out for, example, easing NIH travel restrictions and improving clinical trial recruitment, but I’m confident that these represent positive trends.

Such detail in this Act didn’t happen spontaneously. It was the result of many here at the NIH in the OD working behind the scene to inform Congress about our needs. We owe them our gratitude.